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Pharmacies under scrutiny as meningitis outbreak spreads

From a window positioned over his desk, longtime pharmacist Gary Carlson has a bird's-eye view of lab workers filling IV bags in the sterile production line of Fairview Compounding Pharmacy.

At its busiest the Minneapolis facility can manufacture as many as 20,000 doses in a month of its most popular sterile drug, which it then distributes among the medical system's six hospitals and about 40 clinics.

"They're wearing hairnets and gloves and coats and booties," Carlson said of the facility's workers. "And they're working under what are called laminar flow hoods where the air is filtered so that it is essentially sterile."

Compounding pharmacies have been under intense scrutiny since news emerged that a Massachusetts compounding pharmacy prepared and distributed thousands of vials of contaminated steroids. The drugs have been linked to meningitis infections in more than 200 people in the United States, including several patients in Minnesota. Fifteen people have died.

The outbreak and other health scares linked to compounding pharmacies in recent years have many people demanding stricter oversight of the facilities.

Most pharmacies do at least a little bit of compounding. It may be as simple as crushing up a drug tablet and adding it to a flavored liquid to make the medicine more palatable for small children. But a pharmacy typically isn't considered a true compounding pharmacy unless most of its work involves compounding drugs.

The Minnesota Board of Pharmacy, which licenses and inspects all the pharmacies in the state, estimates there are about a dozen pharmacies that would fit this definition.

Sterile compounding is the most challenging type of pharmacy compounding. One lapse in protocol and an entire batch of drugs can be contaminated with dangerous bacteria or other harmful organisms.

Carlson said Fairview tries to minimize these risks by holding back all of its sterile products for 14 days to make sure they pass a sterility test conducted by an independent lab.

Fairview personnel also are given a skills test every six months that checks whether they are able to prevent bacteria from growing in a broth sample that they manipulate. Every year lab workers must pass a written exam.

"We've never had a problem that got out of here," Carlson said. "Yes, we've had contaminated batches, but we find out about it before we send it out."

The Minnesota Board of Pharmacy cannot verify Carlson's claim that Fairview Compounding Pharmacy has never had any customer problems with its compounded products. But the board's executive director, Cody Wiberg, said he can confirm that the board has never received a complaint about Fairview's compounding facility.

In fact, Wiberg said, the pharmacy board receives very few complaints involving compounding pharmacies. He estimates that of the 125 to 150 complaints the board receives each year, only one or two are related to compounding pharmacies.

Still, it wasn't that long ago that Minnesota did have a serious compounding incident. In 2005 Custom-RX compounding pharmacy in Richfield prepared a product that was linked to vision loss in some patients. Wiberg said the company had to recall its product.

"In that case they were compounding what was supposed to be a sterile ophthalmic preparation that was used by eye surgeons around the country, at least in several states around the country, and it became contaminated with bacteria called pseudomonas," Wiberg said. "And this caused eye infections in people."

Other patient safety incidents have also been linked to compounding pharmacies in recent years. One involved another eye product made by a Florida compounding pharmacy that infected dozens of patients. In another case last year, nine patients died after an intravenous nutrition product made by an Alabama compounding pharmacy was contaminated with bacteria.

"There needs to be more oversight for many of these compounding pharmacies that are serving more as manufacturers," said Allen Vaida, executive vice president of the Institute for Safe Medication Practices based in suburban Philadelphia.

Vaida, a pharmacist, said the U.S. Food and Drug Administration should have more oversight of compounding pharmacies because many states are not up to the task.

"The state boards of pharmacy really don't have the manpower, the funding and the expertise to inspect some of the operations that these compounding pharmacies are performing," he said. "And there's thousands of them out there."

Wiberg, of the Minnesita pharmacy board, said that may be true in some states, but he doesn't think that is the case in Minnesota. Wiberg acknowledges that there was a staff shortage a couple of years ago. But he said the six inspectors he has now are enough to do the job.